YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 341 drug applications between 14 January 2023 and 20 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 87, covering 60 drug names.
2023/01/14 – 2023/01/20
- New acceptances this week
- 341
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- Accepted this week, now under review
- 1
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
341filings, 87 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 162 |
| Generic | 87 |
| New drug | 60 |
| Import | 14 |
| Import re-registration | 10 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 253 |
| TCM | 49 |
| Therapeutic biologic | 36 |
| Prophylactic biologic | 2 |
| Biologic | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 3 | 1 | 23 |
| 2 | Quetiapine Fumarate Tablets | 3 | 1 | 0 |
| 3 | Betamethasone Sodium Phosphate Injection | 2 | 2 | 5 |
| 4 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 5 | Levosimendan Injection | 2 | 2 | 1 |
| 6 | Pentoxifylline Injection | 2 | 2 | 3 |
| 7 | Telmisartan and Hydrochlorothiazide Tablets | 2 | 2 | 2 |
| 8 | Regorafenib Tablets | 2 | 2 | 3 |
| 9 | Ganirelix Injection | 2 | 2 | 1 |
| 10 | Clindamycin Injection | 2 | 1 | 4 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
189 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ping Guang Pharmaceutical Co., Ltd. romanized | 24 | 23 | 1 |
| 2 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 7 | 2 | 1 |
| 3 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 6 | 6 | 3 |
| 4 | Qilu Pharmaceutical Co., Ltd. | 6 | 6 | 5 |
| 5 | MUNDIPHARMA GmbH | 6 | 1 | 0 |
| 6 | Kang Zhi Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 8 | Pfizer Inc. | 5 | 2 | 0 |
| 9 | Jiangxi Shimei Pharmaceutical Co., Ltd | 5 | 2 | 5 |
| 10 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 3 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
94 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/01/20Import · Class 1 | VSA003注射液 · No verified English nameJXHL2300013 | Visirna Therapeutics HK Limited; Visirna Therapeutics (Shanghai) Co Ltd. |
| 2023/01/20Import · Class 1 | Milvexian片 · No verified English nameJXHL2300012 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/01/20Generic · Class 3 | Pentoxifylline InjectionCYHS2300207 | Ping Guang Pharmaceutical Co., Ltd. romanized |
| 2023/01/20Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2300203 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/01/20Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2300199 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2023/01/20New drug · Class 2.2; 2.3 | HYR0201颗粒 · No verified English nameCXZL2300003 | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized |
| 2023/01/20New drug · Class 1 | 注射用SHR-4602 · No verified English nameCXSL2300058 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/01/20New drug · Class 1 | 注射用AP026 · No verified English nameCXSL2300057 | An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/01/20New drug · Class 1 | 甲磺酸贝福替尼胶囊 · No verified English nameCXHS2300016 | Bei Da Pharma Co., Ltd. romanized |
| 2023/01/20New drug · Class 1 | 甲磺酸贝福替尼胶囊 · No verified English nameCXHS2300015 | Bei Da Pharma Co., Ltd. romanized |
| 2023/01/20New drug · Class 2.4 | 甲磺酸伏美替尼片 · No verified English nameCXHL2300110 | Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/20New drug · Class 1 | QHRD107胶囊 · No verified English nameCXHL2300109 | Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized |
| 2023/01/20New drug · Class 1 | QHRD107胶囊 · No verified English nameCXHL2300108 | Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized |
| 2023/01/20New drug · Class 1 | QHRD107胶囊 · No verified English nameCXHL2300107 | Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized |
| 2023/01/20New drug · Class 2.2 | 苯磺酸氨氯地平颗粒 · No verified English nameCXHL2300103 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2023/01/20New drug · Class 2.2 | 苯磺酸氨氯地平颗粒 · No verified English nameCXHL2300102 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2023/01/20New drug · Class 2.2 | 苯磺酸氨氯地平颗粒 · No verified English nameCXHL2300101 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2023/01/20New drug · Class 1 | G201-Na胶囊 · No verified English nameCXHL2300100 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2023/01/20New drug · Class 1 | G201-Na胶囊 · No verified English nameCXHL2300099 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2023/01/19Import · Class 1 | VSA001注射液 · No verified English nameJXHL2300011 | Visirna Therapeutics HK Limited; Visirna Therapeutics (Shanghai) Co Ltd. |
| 2023/01/19Import · Class 1 | BRM421 滴眼液 · No verified English nameJXHL2300010 | BRIM Biotechnology Inc.; Grandpharma (China) Co. Ltd. |
| 2023/01/19Generic · Class 3 | Ornidazole InjectionCYHS2300196 | Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized |
| 2023/01/19Generic · Class 3 | Ornidazole InjectionCYHS2300195 | Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized |
| 2023/01/19Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2300192 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2023/01/19Generic · Class 3 | 醋酸维持液(含葡萄糖) · No verified English nameCYHS2300190 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/01/19Generic · Class 3 | 醋酸维持液(含葡萄糖) · No verified English nameCYHS2300189 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/01/19Generic · Class 3 | Peramivir InjectionCYHS2300186 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2023/01/19Generic · Class 3 | Nimodipine Oral SolutionCYHS2300185 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2023/01/19Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2300183 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2023/01/19Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2300182 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
64 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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